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Tocilizumab Prefilled Syringe

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 5, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04885829Comparative Study of 3 Tocilizumab Products in Normal Healthy VolunteeersPHASE1 COMPLETED 300 — — May 31, 2021May 4, 2023Jan 5, 20244 Australia, India +1
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Study Endpoints
Primary Endpoints
To demonstrate the PK (Pharmacokinetics) similarity of DRL_TC vs RP, DRL_TC vs RMP and RP vs RMP.
Period I pre-dose (1hour prior to drug administration), Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 15, 18, 22, 29, 36, 43 and Period II - Day 1 (dosing), 2 ,3 , 4 , 5 , 6, 7, 9, 11, 15, 18, 22, 29 , 36 , 43 (-2 to +4 days)

AUC0-∞ and AUC0-t will be calculated

To demonstrate the PK (Pharmacokinetics) similarity of DRL_TC vs RP, DRL_TC vs RMP
Period I pre-dose (1hour prior to drug administration), Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 15, 18, 22, 29, 36, 43 and Period II - Day 1 (dosing), 2 ,3 , 4 , 5 , 6, 7, 9, 11, 15, 18, 22, 29 , 36 , 43 (-2 to +4 days)

Cmax will be calculated

Secondary Endpoints
Safety assessment
Screening (Days -28 to -2), Day -1, predose (within 1hour before dosing), post dose (10 minutes, 60 minutes, 4 hours, 8 hours, 12 hours on day 1 and 43) and 24hours, 36hours, 48hours, 60 hours, 72 hours and 84hours after dosing
IL-6 assessment
Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
hsCRP assessment
Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DRL_TCEXPERIMENTALSubcutaneous injection of DRL's Tocilizumab
RP and RMPACTIVE_COMPARATORSubcutaneous injection of Actemra and RoActemra (Commercially available Tocilizumab)
Interventions
NameTypeDescription
Tocilizumab Prefilled SyringeDRUG0.9ml Subcutaneous pre-filled syringes containing 162mg of Tocilizumab.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: 1. Healthy male and female volunteers, 18 to 50 years of age at the time of signing informed consent. 2. In general good health as determined by a qualified physician based on a comprehensive medical history, physical examination including vital signs, laboratory haematology, cl...

Countries:AustraliaIndiaNew Zealand
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Competitive Landscape -Rheumatoid Arthritis 97 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV6PHASE3Upadacitinib, Adalimumab, Tocilizumab, Lutikizumab, Ravagalimab
Eli Lilly and CompanyLLY5PHASE3Baricitinib, Tocilizumab, LY3541860, LY4213663, LY4298445
Bristol-Myers Squibb CompanyBMY6PHASE3Abatacept, Adalimumab, Methotrexate, BMS-986528, CC-97540
Johnson & JohnsonJNJ2PHASE3Ustekinumab, Guselkumab
AstraZeneca PLCAZN4PHASE2AZD1163, AZD0120, AZD5492, Surovatamig
Novartis AG Sponsored ADRNVS4PHASE2VAY736 PFS, VAY736 AI, PIT565, Secukinumab
Merck & Co., Inc.MRK2PHASE2Tulisokibart, Methotrexate, MK-1045
Sanofi SA Sponsored ADRSNY3PHASE2Sarilumab SAR153191, SAR448501, Leflunomide
AnaptysBio, Inc.ANAB1PHASE2Rosnilimab
Spyre Therapeutics, IncSYRE1PHASE2SPY002-072
Immunovant IncIMVT1PHASE2IMVT-1402
XBiotech, Inc.XBIT1PHASE2Natrunix, Methotrexate
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Artiva Biotherapeutics, Inc.ARTV2PHASE2Allogeneic NK Cells, AB-101, Rituximab, Cyclophosphamide, Fludarabine
Gilead Sciences, Inc.GILD1PHASE1GS-0151
Zenas BioPharma, Inc.ZBIO1PHASE1ZB002
Stryker CorporationSYK5NAUndisclosed
Sonoma Pharmaceuticals, Inc.SNOA2PHASE1SBT777101
Zimmer Biomet Holdings, Inc.ZBH29NAUndisclosed
Adicet Bio IncACET1PHASE1ADI-001, Fludarabine, Cyclophosphamide
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